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Safety of Clinical Study Participants

Patient safety is extremely important to us at Seattle Cancer Care Alliance (SCCA). We do everything we can to protect you against unnecessary risks during your treatment, whether you are in a clinical study or not. At the same time, we recognize that no clinical study is without some degree of risk, and we have a number of safety procedures and practices in place.

State, national, and international regulations and policies protect the rights, safety, and well-being of people who are enrolled in clinical studies, also called clinical trials, and ensure the studies are conducted according to strict scientific and ethical principles. In the United States, the Office of Human Research Protections oversees clinical studies and protects study participants. The U.S. Food and Drug Administration (FDA) has authority over clinical studies of drugs, biologics, and medical devices.

Your rights and safety are protected through the clinical study protocol, which undergoes scientific and human subjects–protection reviews and approval, as well as through ongoing monitoring of safety throughout the study.

What Is a Clinical Study Protocol?

All clinical studies follow a plan (protocol) that includes:

The reason for doing the study

Rules about who can join the study (eligibility, or inclusion and exclusion, criteria)

The number of people needed for the study

Details of the treatment and safety information

Schedule and details of tests and evaluations that will be done

Details about information that will be collected from study participants

Eligibility criteria may include many factors, such as a certain type and stage of cancer, previous treatment history, age, gender, medical history, and current health status. Eligibility criteria help protect people from getting treatment that may harm them; these criteria also reduce differences among study participants, which helps ensure that study results are due to the intervention provided rather than other factors.

Who Reviews and Approves a New Study?

At SCCA, study protocols go through internal scientific review, safety review, and clinical review prior to being submitted for review by an institutional review board (IRB), a human subjects–protection entity. IRB review is a federal requirement of all clinical studies: No participants may be enrolled in a clinical study until the protocol has been approved by an IRB.

The IRB is made up of researchers (doctors, nurses, and scientists) and laypeople and is responsible for making sure the rights and welfare of human subjects are protected in studies. The IRB also evaluates proposed studies for ethical research practices, proper attention to safety of participants, and respect for participants’ rights.

What Is Informed Consent?

It is up to you whether to participate in a clinical study. The informed consent process—giving people enough information about the purpose, plan, treatment, tests, procedures, duration, risks, benefits, and alternatives of a study to allow them to make an informed decision—is important to participant safety. Your doctor or nurse should explain the study to you in detail in terms you can understand and answer any questions you may have about the study.

Feel free to ask questions and discuss the study with family and friends so you can make a decision you are comfortable with. If you decide to participate in the study, you will be asked to sign an informed consent form. You must sign the form to enroll in the study before you undergo any procedures that are part of the study.

During the study, researchers must inform you of any new risks, benefits, or side effects they discover.

You can decide to stop participating in the study after signing the informed consent form or at any time during the study. Also, your treatment team may decide before or during the study that it’s not in your best interest to begin or continue in the study—for example, if there’s an unexpected change in your health.

Discuss your decision about participating in or withdrawing from a clinical study with your treatment team. They can tell you how your decision may affect your health and discuss other treatment options with you. Your relationship with your SCCA treatment team and the quality of care provided will not change based on whether you join or stay in a clinical study.

How Are Studies Monitored?

The IRB that approved the study continues to monitor the study while it is in process. This includes conducting reviews of the study at least once a year, reviewing any changes to the study protocol or the informed consent form during the study, and reviewing any new information about the study.

In addition, for some clinical studies—usually Phase III studies—a data and safety monitoring board (DSMB) monitors and reviews the study data periodically to ensure the safety of study participants. The DSMB is an independent committee made up of statisticians and doctors who are experts in clinical research. A study may be stopped early if safety concerns arise or if the answer to the main research question has been answered by the study.

The FDA also may inspect study records and sites to make sure participants are protected and studies are being done correctly.

Special Populations

Some populations, such as children, prisoners, and other groups that may be vulnerable to influence, have additional safeguards to protect them. For example, since children often cannot understand study details, they cannot give true informed consent. Instead, their parents or guardians must give permission for them to participate. Read more about children and clinical studies.